- Daiichi Sankyo, Inc. (Bernards, NJ)
- …when needed Clinical Development Expertise Strategy:In collaboration with the Global Clinical Lead (GCL), if applicable, leads the development and execution ... Medical Monitor (MM):Provides oversight to the CRO MM for clinical data review activitiesMay support addressing eligibility...and updates of the Investigator's Brochure (IB): author the clinical section and lead the development of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …components of a large-scale global clinical program using strong clinical project and program management, leadership, decision -making ability, people ... areas centered around rare diseases and immune disorders. Job Summary: Senior clinical operational leader accountable for operational planning and execution of FIH,… more
- Genmab (NJ)
- …Then we would love to have you join us!The Role & DepartmentThe Feasibility Lead supports the vision and strategy set forth by the Head of Strategic Feasibility. ... assessments, study-level feasibility assessments, robust country and site identification, support of DEI (as applicable), recruitment projections, and any retention… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …teams of functions within the TA Oncology organization. The individual may also support , or lead initiatives intended to expand the Daiichi Sankyo global ... efficient decision makingIn conjunction with finance and Project Management support the Head of Oncology Late-Stage Development in management of budget,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Environmental Monitoring Immediate Action team and Contamination Rapid Response Team in support of on-going clinical and commercial manufacturing as well as ... Legend Biotech is seeking a Contamination Program Lead as part of the Technical Operations team based in Raritan, NJ.Role OverviewThe Contamination Program Lead … more
- Merck & Co. (Boston, MA)
- …of ATs reflect the need of the relevant product and are adequately resourced to support independent decision making.Leads the decision making on timing of ... individuals who lead multi-tumor asset teams (asset team leads). Any clinical development staff reporting to the ATL will be indirect reports.Education:M.D or… more
- Eisai, Inc (Mckinney, TX)
- …expertise to Investigators involved in company sponsored post-marketing studies. Professional Organization Support Lead field medical efforts in support of ... Area Support to External Stakeholders Act as the primary clinical /scientific resource to Healthcare Providers (HCPs) in the territory for information pertaining… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … support submission QAs, perform ad-hoc and exploratory analysis requested by clinical team, and support agency response or potential Advisory Committee ... clinical trials analysis preferred- Advanced understanding of statistical concepts in support of analyses and reporting of clinical trials preferred-… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …development and ultimately improve commercial and clinical planning Design, execute and lead all capability benchmarking projects in support of ET and MPS ... marketing, Sales operations, Market Access and Public Affairs, and enterprise function's clinical and business decision -making is supported by timely, accurate… more
- Formation Bio (NC)
- …& Infrastructure Lead architectural decisions across the data platform to support modularity, scalability, and cost-efficiency. Lead efforts to set standards ... than the industry can progress because of the high cost and time of clinical trials. Recognizing that this development bottleneck may ultimately limit the number of… more
- Merck & Co. (North Wales, PA)
- …Material(s):n/aRequired Skills:Adaptability, Adaptability, Clinical Development, Clinical Research, Cross-Cultural Awareness, Data Analysis, Decision ... Job DescriptionThe Medical Consult and Review Physician provides clinical expertise and advice to internal stakeholders and is a member of several cross-functional… more
- Formation Bio (New York, NY)
- …than the industry can progress because of the high cost and time of clinical trials. Recognizing that this development bottleneck may ultimately limit the number of ... processes, and capabilities to accelerate all aspects of drug development and clinical trials. Formation Bio partners, acquires, or in-licenses drugs from pharma… more
- Formation Bio (New York, NY)
- …advanced analytics, and automation can enhance efficiency, reduce timelines, and support decision -making in biologics development and manufacturing. Project ... than the industry can progress because of the high cost and time of clinical trials. Recognizing that this development bottleneck may ultimately limit the number of… more
- Eisai, Inc (Exton, PA)
- …Functions 1. Oversee the operations of the Upstream and Downstream Operations groups to support the supply of DS/ADI for pre- clinical and phase I to phase ... Downstream production staff in the operation of equipment to support preclinical and phase I to III clinical...III and PV at CMOs at the company's discretion.5. Lead and assist in troubleshooting upstream and downstream process,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Global QMS (RD PV QA) and is a member of the leadership team. Lead an enterprise cross-functional QA team to deliver state-of-the-art data-driven solutions.Design a ... line functions. Set the strategic direction to define best approach for clinical development systems, PV systems and MA systems including data management,… more
- Merck & Co. (South San Francisco, CA)
- …ADME, discovery bioanalytics and modeling partners to support lead identification/optimization, enable FIH translation, and compile non- clinical packages ... partners in project teams to facilitate program progression through science-based decision making. The successful candidate must demonstrate the ability to work… more
- Merck & Co. (Rahway, NJ)
- …analytics capabilities and tools anchored to our marketing and launch frameworks to support decision making for Global Vaccines portfolio and assets (eg market ... via active updates to ongoing inventory of projects/initiatives (Book of Work). Support taxonomy implementation & updates.Team Management: Lead a high performing… more
- Merck & Co. (Rahway, NJ)
- …tools to support pharmaceutical researchers in predicting drug behavior, improving decision -making, and accelerating the path to market. The goal of this product ... the RaDS Product organization. The position will report to the- Lead of the Disease Biology and PharmTox Product Line....vendors of predictive and modeling and simulation tools supporting pre- clinical and non- clinical development, and data to… more
- Merck & Co. (North Wales, PA)
- …and Indirect (eg, partnering with CMC, Labeling, etc ) e xecution activities that support Data-based Submissions ( eg XEVMPD, IDMP, PQCMC, SPL etc . )- - Internal ... for GRACS and other critical stakeholder areas including PV, Clinical and Supply Chain to ensure that datasets are...are not limited to: - - Data Centric Submissions: Lead the data submissions team that is accountable for… more
- Aequor (Thousand Oaks, CA)
- …This "Specialist Manufacturing" role will serve as a New Product Introduction Lead within the New Product Introduction, Manufacturing Execution Systems, and Digital ... team at ATO B20. The NPI Lead is expected to have ownership over the Technology...vital to the impact that ATO B20 with a clinical and commercial product mix has to the network.… more
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